Laboratory Ethics

Presentation to: KWWOA

April 17, 2013

Department for Environmental ProtectionEnergy & Environment Cabinet

To Protect and Enhance Kentucky’s Environment

Ethics

Ethics is defined as:

“A code of right and wrong that dictates personal and professional conduct”.

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Examples of Unethical Behavior

• Fabricating data;• Improper clock settings to meet hold times;• Misrepresenting quality control samples;• Calibrating equipment using other than

accepted procedures;• Modifying samples to alter characteristics;• Substituting samples, files, and/or data;

Continued 3

Unethical Behavior Examples (cont)

• Falsifying records of analytical equipment readings;

• Intentional deletion of non-compliant data;• Improper handling of data errors, non-

compliant data, or QC outliers;• Lack of reporting unethical behavior of others.

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Fraud

Fraud is defined as:

“an intentional act of deceit that may result in legal prosecution”.

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Laboratory Fraud

Laboratory fraud is defined as:

“the deliberate falsification of analytical and quality assurance results, where failed method and contractual requirements are made to appear acceptable during reporting”.

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QA Programs & Ethics

Traditional laboratory QA Programs fall short in addressing unethical behavior:

1. Ineffective oversight of laboratory data;

2. Focusing on production over quality; and

3. “One size fits all” approach to analytical requirements.

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Where Fraud Occurs

Organics – 54%

Entire Lab – 17 %

Inorganics- 14 %

Microbiology – 6%

Other – 9 %

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Bad Versus Fraudulent Data

Incorrect data may either be the result of “bad” techniques, training or human error.

Fraudulent data is the result of an individual purposefully misrepresenting data that does not conform to a given set of standards or criteria and making it appear as if it does.

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Producing Fraudulent Data• Dry labbing;• Time traveling;• Juicing;• Improper GC/MS tuning;• Improper calibration / QC analysis;• Peak shaving;• Misrepresentation of QC samples;

Continued10

Producing Fraudulent Data (cont)• File substitution;• Unwarranted manipulation of computer

software;• Improper alteration of analytical conditions;• Over dilution of samples or misrepresentation

of detection limits;• Deletion of non-compliant data;• Concealment of a known problem.

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Dry Labbing

Creating data for an analysis that was not performed or creating information that is not true.

John Tlumacki /Boston Globe

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Dry Labbing Scenario

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Time Traveling

Resetting the internal clock on an instrument to make it appear that a sample(s) was analyzed within a specified holding time when in fact it was not.

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Juicing

Adding more surrogate, spike or tuning compound mixture to a QC sample or water sample to increase the response factor of certain compounds which are typically responsible for out-of-control responses compared to QC criteria.

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Improper GC/MS Tuning

Artificially manipulating GC/MS tuning data to produce an ion abundance result that appears to meet specific QC criteria when in fact the criteria were not met.

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Improper Calibration / QC Analysis

• Not following accepted procedures for out-of-compliant ICAL results;

• Inserting previously run ICAL files into the current ICAL;

• Discarding ICAL points to force the calibration to meet acceptance criteria.

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Peak Shaving (GC & GC/MS)

Artificially subtracting or adding peak area to produce an erroneous area that forces data to meet specific QC criteria when in fact the criteria were not met.

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Peak Shaving Examples

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Elevated Baseline Tail Removal Combination

Proper Integration Improper Integration

Peak Shaving Examples

Peak Addition Examples

Proper Improper

Misrepresentation of QC and Spikes

• Adding surrogates after sample extraction rather than prior to sample extraction

• Reporting post-digestion spikes or duplicates as pre-digested spikes or duplicates

• Not preparing or analyzing method blanks or LCS’s along with batch samples. Simply adding solvent to the final sample prior to instrument analysis.

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File Substitution

Substituting previously generated files (runs) for a non-compliant calibration or QC run to make it appear that an acceptable run was performed when in fact it was not.

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Manipulation of Computer Software

Unwarranted manipulation of computer software to force calibration or QC data to meet criteria, and removing computer operational codes, such as “M” flag.

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Improper Alteration of Conditions

Improperly altering analytical conditions, such as changing the instrument conditions for sample analyses from those used for standard analyses. Also using different procedures to process sample data than those used for standards.

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Intentional Over Dilution of Samples

Intentionally diluting a sample to such an extent that no analytes (target or non-target) are detected without justification as to why the higher dilution was made.

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Deletion of Non-Compliant Data

Intentional deletion or non-recording of non-compliant data to conceal the fact that analyses were non-compliant.

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Concealment of a Known Problem

Concealing a known analytical or sample problem from laboratory management and/or client. Concealing a known unethical behavior or action from laboratory or corporate management.

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Reasons Why

• Shrinking market;• Low prices = “cutting corners”;• Insufficient resources / training;• Unclear management position;• Employee perception;• Employee personal issues.

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Fraud Is Difficult To Prove

• Intentional manipulation of data is performed for the sole purpose of misleading the data user.

• These manipulations are often subtle and well hidden within the electronic media or internal laboratory notes, which are not made part of a typical sample report.

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General Effect of Fraudulent Data

• Lose of data, time, and money;• Public health jeopardized;• Laboratory’s loss of credibility;• Individual’s loss of credibility.

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Repercussions

• Inaccurate or inappropriate changes to plant operating conditions;

• Incorrect data reported to regulators;• May place public at risk;• Employment implications;• Criminal implications:

– Fraud is a felony in Kentucky – no statute of limitations.

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What Can You Do About Lab Fraud

What Laboratory Management and

Analyst’s Needs To Do

What a Public Water System Can Do

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Laboratory Owner / Management• Adopt an ethics & data integrity program• Include a zero tolerance policy• Perform internal compliance audits• Establish employee assistance and reporting

mechanism• Provide employee ethics training

Continued

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Laboratory Owner / Management (cont)

• Let the analysts know that mistakes are ok but hiding mistakes is not

• Develop written procedures for reporting mistakes

• Establish written procedures for manual integrations

• Circulate relevant news stories to help promote discussions of laboratory ethics

Continued33

Laboratory Owner / Management (cont)

• Inform all new analysts of the consequences of fraudulent activity

• QA Managers should establish a rapport with the analysts and make frequent trips through the lab areas

• Stress quality of results over quantity of results

• Ethics agreements with all employees

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Example Ethics Agreement

I, ________ (Name), state that I understand the high standards of integrity required of me with regard to the duties I perform and the data I report in connection with my employment at ___________ (Laboratory).

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Example Ethics Agreement (cont.)

I agree that in the performance of my duties:

a. I shall not intentionally report data values that are not actual values obtained;

b. I shall not intentionally report dates and times of data analyses that are not the actual dates and times of data analyses; and

c. I shall not intentionally represent another individual’s work as my own.

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Example Ethics Agreement (cont.)

I agree to inform _____ (Laboratory) of any accidental reporting of non-authentic data by myself in a timely manner.

I agree to inform _____ (Laboratory) of any accidental or intentional reporting of non-authentic data by other employees.

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Laboratory Analysts Code of Conduct

Uphold the values, ethics and policy statement of your company and your profession.

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Analysts Code of Conduct (cont.)

Conduct all professional activities with honesty, integrity, respect, fairness and good faith.

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Analysts Code of Conduct (cont.)

Be truthful in all forms of professional communication and avoid disseminating information that is false, misleading, or deceptive.

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Analysts Code of Conduct (cont.)

Act responsibly to uphold the integrity of your profession.

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Analysts Code of Conduct (cont.)

Report any observation of suspicious, unethical, or illegal behavior to the proper authorities.

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What a PWS Can Do

• Utilize more than one contract laboratory• Establish contractual agreements for

laboratory analysis• Consider third party experts

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Use More Than One Laboratory

• Reduces / eliminates overload• Split-sample opportunities• Similar results build confidence with clients• Helps to ensure that key decisions are not

based on a single data source

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Contractual Agreements

• Boiler plate language is available• QA/QC requirements should be included• DQO requirements should be included• Specify intended use of the data• Pertinent documents must be included (or

referenced) in the agreement

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Consider Third-party Experts

• Perform on-site evaluations (audits)• Provide added value to the program• Additional cost• Independent parties with respect to business

decisions, laboratory, findings, report, etc.• Deterrent to potential fraud

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Currently…

• EPA considering update to Manual for Laboratories Analyzing Drinking Water Samples;

• For more information, visit the following http:www.fda.gov/opacom/laws/addlenf.htm

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To Report Fraud in Kentucky

EPPC Office of the Inspector General

OIG Hotline: 1-888-564-0498Email: mark.kennedy@ky.gov

www.eppcoig.ky.gov/hotline/

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Questions

?

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Further Reading

• Region 9 – Best Practices for the Detection and Deterrence of Laboratory Fraud

• EPA Guidance on Assessing Quality Systems; EPA QA/G-3• EPA Guidance on Developing a Training Program for Quality

Systems; EPA QA/G-10• On Being a Scientist: Responsible Conduct in Research; 1995,

National Academy of Sciences.• A summary of General Assessment Factors for Evaluating the

Quality of Scientific and Technical Information; EPA’s Science Policy Council, 2003; EPA 100B/B-03/001.

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References• Laboratory Fraud – We are still here…; Bruce A. Woods

Ph.D., USEPA Office of Inspector General; PowerPoint.• Region 9 – Best Practices for the Detection and Deterrence

of Laboratory Fraud.• The Chemical Professional’s Code of Conduct; http://

portal.acs.org/portal/acs/corg/content.• Ethics & Data Integrity; Stephanie Drier, MN-ELAP;

Presented at MWOA Summer Workshop, June 10, 2010.• Ethics Education and Practices in the Laboratory; Ann

Rosecrance; Core Laboratories, 6316 Windfern, Houston, TX 77040.

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Contact InformationKevin Stewart

Laboratory Certification OfficerDivision of Water

200 Fair Oaks Lane; 4th FloorFrankfort, KY 40601

Phone: (502) 564-3410Fax: (502) 564-2741

Email: kevin.stewart@ky.gov

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